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NDC 43538-0940-60 Neo-Synalar .25; 3.5 mg/g; mg/g Details
Neo-Synalar .25; 3.5 mg/g; mg/g
Neo-Synalar is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Medimetriks Pharmaceuticals. The primary component is FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE.
MedlinePlus Drug Summary
Fluocinolone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Fluocinolone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Related Packages: 43538-0940-60Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluocinolone Topical
Neomycin, an antibiotic, is used to prevent or treat skin infections caused by bacteria. It is not effective against fungal or viral infections. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 43538-0940-60Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Neomycin Topical
Product Information
| NDC | 43538-0940 |
|---|---|
| Product ID | 43538-940_4b6c5088-fd92-4793-8010-f2b20f9fe44a |
| Associated GPIs | 90109902203710 |
| GCN Sequence Number | 026482 |
| GCN Sequence Number Description | neomycin sulfate/fluocinolone CREAM (G) 0.5-0.025% TOPICAL |
| HIC3 | Q5X |
| HIC3 Description | TOPICAL ANTIBIOTIC AND ANTI-INFLAMMATORY STEROID |
| GCN | 55412 |
| HICL Sequence Number | 003378 |
| HICL Sequence Number Description | NEOMYCIN SULFATE/FLUOCINOLONE ACETONIDE |
| Brand/Generic | Brand |
| Proprietary Name | Neo-Synalar |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | neomycin sulfate and fluocinolone acetonide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | .25; 3.5 |
| Active Ingredient Units | mg/g; mg/g |
| Substance Name | FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE |
| Labeler Name | Medimetriks Pharmaceuticals |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA060700 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43538-0940-60 (43538094060)
| NDC Package Code | 43538-940-60 |
|---|---|
| Billing NDC | 43538094060 |
| Package | 1 TUBE in 1 CARTON (43538-940-60) / 60 g in 1 TUBE |
| Marketing Start Date | 1963-06-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |